UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041660 |
|---|---|
| Receipt number | R000047548 |
| Scientific Title | The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2021/09/04 18:35:53 |
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Basic information
Public title
The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Acronym
The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Scientific Title
The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Scientific Title:Acronym
The efficacy of SSP (Silver Spike Point) therapy for refractory urinary incontinence
Region
| Japan |
Condition
Condition
Refractory urinary incontinence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the usefulness of SSP therapy in refractory urinary incontinence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change from baseline in total points on the Overactive Bladder Symptom Score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SSP therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with refractory urinary incontinence
Key exclusion criteria
The women who are pregnant or who may be pregnant and so on
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yamanishi |
Organization
Dokkyo Medical University Hospital
Division name
Department of Urology, Continence Center
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
yamanish@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Dokkyo Medical University Hospital
Division name
Department of Urology, Continence Center
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
Homepage URL
k-kaga@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Tochigi
Tel
0282-86-1111
k-kaga@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047548
